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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8806
Device Problem Fluid Leak (1250)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
Udi -- (b)(4). Attempts are being made to obtain additional information. Upon receipt of new relevant information, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, after 11 days, a hakim valve was suspected of leaking and was revised. Initial setting were unknown. However, cerebrospinal fluid was confirmed to be collected around the implanted valve near the iliac bone. It was suspected that cerebrospinal fluid could be leaking, therefore, a revision surgery was performed. The product will be returned. There was no confirmation of pin holes or leakage from connection parts.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle MA CH 24 00
SZ CH 2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle MA CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8190387
MDR Text Key131183022
Report Number1226348-2018-10909
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-8806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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